Effectiveness and Safety of Yiqitongluo Granule for Stroke

Stroke Clinical Trial

Official title:

Phase IV Clinical Trial of Yiqitongluo Granule in the Treatment of Stroke With Qi-deficiency and Blood-stasis Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604654
• Other study ID #: SWYY-YQTLKL
• Status: Completed
• Phase: Phase 4
• Start date: December 29, 2015
• Est. completion date: December 6, 2017

Study information

• Verified date: July 2020
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the prospective study is to evaluate the effectiveness and safety of Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more than sixy hospitals all over China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2197
• Est. completion date: December 6, 2017
• Est. primary completion date: November 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• mild and moderate ischemic stroke patient with 4-25 NIHSS score

• stable patients within 1 week to 3 months

• sign informed consent before study

Exclusion Criteria:

• CT shows cerebral hemorrhage disease: such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, and subarachnoid hemorrhage

• severe disturbance of consciousness

• dysphagia

• TIA

• hemorrhagic diathesis

• patient with malignant tumor whose expected lifetime is less than 3 months

• allergic constitution

• gestation period, lactation period, woman with the possibility or plan of pregnancy

• those who participated in other clinical trials within 3 months or taking part in other clinical trials

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Yiqitongluo granule
administered after dissolved

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yi Yang	Shineway Pharmaceutical Co.,Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Yiqitongluo for stroke measured by laboratory index		change from baseline laboratory index at 28(±7) days
Secondary	Effect of Yiqitongluo for stroke with mRS	mRS: modified Rankin Scale	90(±7) days
Secondary	Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine		28(±7) days
Secondary	Effect of Yiqitongluo for stroke with NIHSS	NIHSS: the NIH stroke scale	28(±7) days
Secondary	Effect of Yiqitongluo for stroke with BI	BI: Barthel Index	28(±7) days
Secondary	Effect of Yiqitongluo for stroke with EQ-5D	The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.	28(±7) days